LawyersandSettlements (LAS): How can the Mirena IUD migrate?
Dr. Shezad Malik (SM): The Mirena IUD is a small T- shaped device placed in the uterus that is supposed to be hassle free for up to five years. Convenience is the manufacturer’s big selling point, but while they were busy marketing their product, nobody warned about injuries after the device has been implanted for some time. The Mirena causes perforation either because there is a problem with the device’s design or because it releases the synthetic progestin levonorgestrel (also known as “the morning after pill”), which can thin out the uterus or cervix and thereby cause the device to perforate. If the uterus or cervix is extra thin and you introduce a hard plastic body, chances are, perforations can occur.
LAS: In recent court documents, plaintiffs claim that Bayer only warns that migration can occur if the uterus is punctured during the IUD’s initial implantation. Is Bayer trying to blame doctors?
SM: Sometimes health providers are at fault, such as when nurse practitioners insert the Mirena rather than a doctor. There could be a technical problem because the device has to go through the vaginal canal.
LAS: What are the symptoms of Mirena perforation during insertion?
SM: A woman who is punctured by the IUD immediately or shortly after insertion will have intense pain. As well, women are supposed to see their health care provider on an annual basis to see if the string is still attached. If the Mirena can be pulled out with a tug on the strings, that is OK. If not, that is a sure indicator of embedment and/or perforation.
Continual pain is a sign that something is wrong. A foreign body, such as an IUD, will cause some inflammation: a hostile environment for an embryo has been introduced to the body. However, the pain usually passes as the body adapts, but if you have continual pain that gets worse, that is an indication of a perforation. Or if you experience discomfort and tenderness after some time has elapsed, seek medical attention. If there is any inflammation or pain, it is possible that the Mirena has migrated and an ultrasound or x-ray should be ordered to find out exactly where it is.
LAS: Plaintiffs in an MDL must have similar complaints. Do MDL plaintiffs have to show exactly the same side effects?
SM: There is a litany of complaints regarding Mirena with infections and intra-uterine pregnancies, but at this time the only cases are perforations of the uterus or embedment in the uterine wall that requires surgery to have the device removed.
LAS: What does the current multidistrict litigation (MDL) allege against Bayer?
SM: All of these lawsuits accuse Bayer Healthcare Pharmaceuticals of failing to provide adequate warnings regarding the potential for Mirena to migrate from its proper position in the uterus long after it has been correctly inserted by a health care provider.
LAS: What is Bayer’s strategy?
SM: The big push from Bayer is to kick out cases past the Statute of Limitations (SOL). First, check the limitations in your state (some states stipulate one year and some are more than three years, but most states have two-year statutes of limitations).
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LAS: Has a date been slated for trial?
SM: Early trials will be set up for bellwether trials. Currently, a list is being drawn up for trial selections, which will happen some time in late 2015. There will be expert testimony based on these cases. In the meantime, Bayer will attempt to get rid of these SOL cases - they are making the SOL argument in June.
LAS: Are Mirena attorneys still accepting Mirena claims?
SM: Yes. Women are still filing claims within their SOL. Before calling an attorney, try to determine the date when you knew or should have known perforation and when you went to the doctor. So seek legal advice sooner than later.